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09/03/2014 at 08:45 am.

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Start Preamble

ACTION:

Notice of registration.

Start Printed Page 52763

SUMMARY:

Mylan Technologies, Inc., applied to be registered as an importer of certain basic classes of controlled substances. The DEA grants Mylan Technologies, Inc., registration as an importer of those controlled substances.

End PreambleStart Supplemental Information

SUPPLEMENTARY INFORMATION:

By notice dated May 28, 2014, and published in the Federal Register on June 4, 2014, 79 FR 32316, Mylan Technologies, Inc., 110 Lake Street, Saint Albans, Vermont 05478, applied to be registered as an importer of certain basic classes of controlled substances. No comments or objections were submitted for this notice.

The Drug Enforcement Administration (DEA) has considered the factors in 21 U.S.C. 823, 952(a) and 958(a) and determined that the registration of Mylan Technologies, Inc., to import the basic classes of controlled substances is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. The DEA investigated the company's maintenance of effective controls against diversion by inspecting and testing the company's physical security systems, verifying the company's compliance with state and local laws, and reviewing the company's background and history.

Therefore, pursuant to 21 U.S.C. 952(a) and 958(a), and in accordance with 21 CFR 1301.34, the above named company is granted registration as an importer of the basic classes of controlled substances listed:

Controlled substance

Schedule

Methylphenidate (1724)

II

Fentanyl (9801)

II

The company plans to import the listed controlled substances in finished dosage form (FDF) from foreign sources for analytical testing and clinical trials in which the foreign FDF will be compared to the company's own domestically-manufactured FDF. This analysis is required to allow the company to export domestically-manufactured FDF to foreign markets.